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NCT01119573 Clinical Trial

Biomarkers in Tissue Samples From Patients With Stage I or Stage III Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:
Micro RNA's Associated With Lymph Node Metastasis in Endometrial Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01119573
Other study ID # CDR0000672415
Secondary ID GOG-8014
Status Not yet recruiting
Phase N/A
First received May 6, 2010
Last updated June 17, 2010
Start date May 2010

Study information
Verified date May 2010
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying at biomarkers in tissue samples from patients with stage I or stage III endometrial cancer.

Description:

OBJECTIVES:

- To identify microRNA expression patterns associated with lymph node metastasis in samples from patients with endometrial cancer.

OUTLINE: Banked tumor tissue specimens are analyzed for microRNA expression profiling by microarray analysis and reverse transcriptase-PCR assays.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility DISEASE CHARACTERISTICS:

- Histologically confirmed endometrioid endometrial cancer

- Stage IA, IB, IC, or IIIC disease

- Any grade

- Enrolled and evaluated on GOG-0210 Molecular Staging Study of Endometrial Cancer

- Consented to allow their specimens and clinical data to be collected and stored for future research

- Underwent complete surgical staging, including the following:

- Hysterectomy

- Bilateral oophorectomy

- Washings as well as pelvic lymphadenectomy (sampling of four left and four right pelvic lymph nodes)

- Para-aortic lymphadenectomy (sampling of one left and one right para-aortic lymph node)

- Sufficient high-quality frozen primary tumor for testing with = 75% tumor cellularity and = 10% necrosis

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Genetic:
• RNA analysis

• microarray analysis

• reverse transcriptase-polymerase chain reaction

Other:
• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Gynecologic Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Association between microRNA expression and lymph node metastasis No
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